MAUDE Adverse Event Report: LEPTO LASIK; EXCIMER LASER SYSTEM

Device Problems Patient-Device Incompatibility (2682); Human-Device Interface Problem (2949); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Dry Eye(s) (1814); Headache (1880); Blurred Vision (2137); Depression (2361); Eye Pain (4467); Increased Sensitivity (4538)

Event Date 03/22/2019

Event Type  Injury  

Event Description

I was contact lens user around 10-12 years, i never feel dry eyes.After lasik i became patient of dry eye.I saw my report.My doctor didn't perform schirmer test, no eye drops was prescribed before lasik, i just discontinued my scl (soft contact lenses) five days before lasik eye surgery, as per my doctor.It has been three years my eye dryness is increasing.I guess more than a year for dry eye, i have become the patient of dry eye and which is getting worse by age.My surgeon confirmed to me lasik is permanent solution to remove "spect" and contact lenses.From day one i was not able to see clearly from right eye, within two years my eye power back, i am not able see clearly without glasses.My power is 0.50 in left and 0.75 in right with cylindrical.Multiple doctors confirmed but my doctor did not accept this and i feel pain from eye to head, from last four months i feel continuous chronic pain in my right eye.Which is affecting my day to day life.My right eye was already weak before lasik which my doctor didn't tell me.I was misguided by my surgeon from day one.I asked for smile surgery, he suggested and did lepto lasik surgery, which i have doubt after my eye condition.He had not mentioned lasik side effects like, i became astigmatism; earlier i was not.I can't see clearly in night after "spect".Also, i have doubts if i require any eye surgery in future that my eyes will accept that.I am facing light issue especially in driving, continuous headache, i can't go outside in windy area without "spect", etc.Before surgery they have suggested any consent form, they have given me consent form after dilate my eye and just before surgery, so i can't read it.He assured me i can use contact lenses which i have tried at my "marriage" then i realize my eyes are not accepting lenses any more.Lasik eye surgery makes me partially "bling" person, i have to live my life with "spect" with lots of complications.These dry eyes, headache putting me in depression because i am not able to give my 100% at any job and i am not working since two years.I was not stepping outside around 2-3 months.I became patient of unidentified neurologic "patient (b)(6)." "which got paint in eyes and head" but didn't come anything in mri and reports.Who has given the right to fda and dr (physician) for playing with patient's life? without any body part patient can survive but without eyes it's not possible.Before surgery they have not performed any test like diabetes, aids (acquired immune deficiency syndrome), bp (blood pressure), etc.It should be there because i have genetic diabetes issues in my family, which can create problem to me in the future.There is changes for lasik patient to get cataract at early stage.I am not writing anything new; all these issues are common for fda.There should be some action against dr.(physician) for misleading communication, advertisement, nor information, major complication to the patient, destroying quality of life, make my future uncertain, i don't know till how long my eyes will support me.All these side effects and facts after lasik were not informed to me by my doctor, it's informed by another doctor while i have started consult with multiple doctors.They told me the lasik side effects and future facts.(b)(6).

• Brand Name: LEPTO LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 17086430
• MDR Text Key: 316868885
• Report Number: MW5118269
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female